Sacral Spread of Sensory Block After Dural Puncture Epidural Technique Compared With Epidural for Labour Analgesia

NCT05217134 | Completed

• 1 other identifier: 4294
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

Neuraxial labor analgesia is a very widely used technique for labor pain relief with a high efficacy and safety. EA (Epidural analgesia) can guarantee a proper control of pain in 95-100% of cases in the first stage of labor, but in the second stage his efficacy is not always adequate. DPEA (Dural Puncture Epidural Analgesia) is a variation of the conventional EA and technically a modified version of the CSE (Combined Spinal Epidural) analgesia. When compared with the traditional EA, DPEA showed satisfying, effective and fast control of labor pain, no motor block and less need for anesthetic boluses given through the epidural catheter when the maintenance of analgesia was guaranteed with manual top-ups, as well as less request for extra boluses of anesthetic when PIEB (Programmed Intermittent Epidural Boluses) was chosen for the maintenance of analgesia. Studies proved that DPEA is a safe technique and no statistically significant incidence of side effects for mothers and fetuses was observed. The hypothesis of this study is that a DPEA performed with a 27 G Whitacre spinal needle can especially improve the spread in the sacral region. The primary outcome of this study is to evaluate whether the DPEA performed with a 27-G Whitacre spinal needle is more effective in ensuring satisfying analgesia as a result of a better sacral analgesic spread, compared to the traditional EA.

Conditions

Labor Pain; Analgesia

Keywords

Dural Puncture Epidural Analgesia; Sacral pain

Outcome Measures

Primary Outcomes (1)

• Evaluation of sensitive block through a pin-prik test in lumbar and sacral dermatomes.

  Efficacy of sacral anesthetic block through a pin-prik test (0= no sensitive block, 2= complete block) in lumbar and sacral dermatomes: stimulation of the inguinal ligament (L1), the anterior portion of the thigh (L2), the medial surface of the knee (L3), the medial malleolus (L4), the back of the foot in the space between the first two metatarsal rays (L5), the lateral surface of the heel (S1) and the medial popliteal fossa (S2).

  20 minutes after completion of anesthesia.

Secondary Outcomes (2)

• Change of pain relief

  10 minutes, 20 minutes, 30 minutes and then every 1 hour after completion of anesthesia.

• Supplemental analgesia requirement

  20 minutes after delivery.

Study Arms (2)

Dural Puncture Epidural Analgesia (DPEA)

EXPERIMENTAL

A 27-Whitacre spinal needle puncture will be performed with confirmation of LCR return, before the introduction of epidural catheter.

Procedure: DPEA

Epidural Analgesia (EA)

NO INTERVENTION

Standard epidural anesthesia wil be performed.

Interventions

DPEA PROCEDURE

Dural puncture with 27 G Whitacre needle

Dural Puncture Epidural Analgesia (DPEA)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• nulliparous;
• gestational week;
• active stage of labor;
• less than 5 cm cervical dilatation.

You may not qualify if:

• \< 18 years;
• ASA \> 2;
• refusal of informed consent;
• known fetal pathologies;
• conditions that contraindicate the execution of neuro axial analgesia techniques;
• uterine anomalies or previous uterine surgery;
• severe obesity;
• twin pregnancy;
• non-vertex fetal presentation.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Luciano Frassanito

Rome, 00168, Italy

Location

Related Publications (7)

• Gunaydin B, Erel S. How neuraxial labor analgesia differs by approach: dural puncture epidural as a novel option. J Anesth. 2019 Feb;33(1):125-130. doi: 10.1007/s00540-018-2564-y. Epub 2018 Oct 6.

  PMID: 30293143 RESULT

• Shmueli A, Salman L, Orbach-Zinger S, Aviram A, Hiersch L, Chen R, Gabbay-Benziv R. The impact of epidural analgesia on the duration of the second stage of labor. Birth. 2018 Dec;45(4):377-384. doi: 10.1111/birt.12355. Epub 2018 May 22.

  PMID: 29790194 RESULT

• Chau A, Bibbo C, Huang CC, Elterman KG, Cappiello EC, Robinson JN, Tsen LC. Dural Puncture Epidural Technique Improves Labor Analgesia Quality With Fewer Side Effects Compared With Epidural and Combined Spinal Epidural Techniques: A Randomized Clinical Trial. Anesth Analg. 2017 Feb;124(2):560-569. doi: 10.1213/ANE.0000000000001798.

  PMID: 28067707 RESULT

• Contreras F, Morales J, Bravo D, Layera S, Jara A, Riano C, Pizarro R, De La Fuente N, Aliste J, Finlayson RJ, Tran DQ. Dural puncture epidural analgesia for labor: a randomized comparison between 25-gauge and 27-gauge pencil point spinal needles. Reg Anesth Pain Med. 2019 May 22:rapm-2019-100608. doi: 10.1136/rapm-2019-100608. Online ahead of print.

  PMID: 31118278 RESULT

• Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.

  PMID: 18931227 RESULT

• Thomas JA, Pan PH, Harris LC, Owen MD, D'Angelo R. Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function. Anesthesiology. 2005 Nov;103(5):1046-51. doi: 10.1097/00000542-200511000-00019.

  PMID: 16249679 RESULT

• Song Y, Du W, Zhou S, Zhou Y, Yu Y, Xu Z, Liu Z. Effect of Dural Puncture Epidural Technique Combined With Programmed Intermittent Epidural Bolus on Labor Analgesia Onset and Maintenance: A Randomized Controlled Trial. Anesth Analg. 2021 Apr 1;132(4):971-978. doi: 10.1213/ANE.0000000000004768.

  PMID: 32282386 RESULT

MeSH Terms

Conditions

Labor Pain; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: February 1, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: September 1, 2022
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

IT (2)